Ontrak, Inc. - Quarter Report: 2005 September (Form 10-Q)
Table of Contents
United States SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
OF THE SECURITIES EXCHANGE ACT OF 1934
For The Quarterly Period Ended September 30, 2005
Commission File Number 001-31932
HYTHIAM, INC.
(Exact name of registrant as specified in its charter)
Delaware | 88-0464853 | |
(State or other jurisdiction of incorporation) | (I.R.S. Employer Identification Number) |
11150 Santa Monica Boulevard, Suite 1500, Los Angeles, California 90025
(Address of principal executive offices, including zip code)
(Address of principal executive offices, including zip code)
(310) 444-4300
(Registrants telephone number, including area code)
(Registrants telephone number, including area code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of
the Exchange Act).
Yes o No þ
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
Yes o No þ
As of November 14, 2005, there were 38,278,758 shares of registrants common stock, $0.0001 par
value, outstanding.
INDEX
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PART I FINANCIAL INFORMATION
ITEM 1. Financial Statements
HYTHIAM, INC. AND SUBSIDIARIES
(a Development Stage Company)
(a Development Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS
September 30, | December 31, | |||||||
(Dollars in thousands, except share data) | 2005 | 2004 | ||||||
ASSETS |
||||||||
Current assets |
||||||||
Cash and cash equivalents |
$ | 3,450 | $ | 4,000 | ||||
Marketable securities |
10,513 | 23,479 | ||||||
Restricted cash and marketable securities |
65 | | ||||||
Receivables, net |
299 | 168 | ||||||
Prepaids and other current assets |
560 | 446 | ||||||
Total current assets |
14,887 | 28,093 | ||||||
Long-term assets |
||||||||
Property and equipment, less accumulated depreciation of
$975 and $516, respectively |
2,872 | 2,424 | ||||||
Intellectual property, less accumulated amortiation of
$379 and $219, respectively |
3,072 | 3,080 | ||||||
Deposits and other assets |
779 | 365 | ||||||
$ | 21,610 | $ | 33,962 | |||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current liabilities |
||||||||
Accounts payable |
$ | 2,239 | $ | 609 | ||||
Accrued compensation and benefits |
787 | 826 | ||||||
Other accrued liabilities |
182 | 329 | ||||||
Total current liabilities |
3,208 | 1,764 | ||||||
Long-term liabilities |
||||||||
Deferred rent liability |
497 | 364 | ||||||
Commitments and contingencies |
||||||||
Stockholders equity |
||||||||
Preferred stock, $ par value; 50,000,000 shares authorized; no shares
issued and outstanding |
| | ||||||
Common stock, $ par value; 200,000,000 shares authorized;
30,271,000 and 30,111,000 shares issued and 29,911,000
and 29,751,000 shares outstanding at September 30, 2005 and December 31, 2004, respectively |
3 | 3 | ||||||
Additional paid-in-capital |
48,920 | 47,234 | ||||||
Deficit accumulated during the development stage |
(31,018 | ) | (15,403 | ) | ||||
17,905 | 31,834 | |||||||
$ | 21,610 | $ | 33,962 | |||||
See accompanying notes to financial statements.
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HYTHIAM, INC. AND SUBSIDIARIES
(a Development Stage Company)
(a Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
Period from | ||||||||||||||||||||
February 13, | ||||||||||||||||||||
Three Months Ended | Nine Months Ended | 2003 (Inception) | ||||||||||||||||||
September 30, | September 30, | to September 30, | ||||||||||||||||||
(In thousands, except per share amounts) | 2005 | 2004 | 2005 | 2004 | 2005 | |||||||||||||||
Revenues |
$ | 361 | $ | 41 | $ | 794 | $ | 113 | $ | 1,061 | ||||||||||
Operating Expenses |
||||||||||||||||||||
Salaries and benefits |
2,452 | 1,308 | 6,323 | 3,994 | 13,057 | |||||||||||||||
Other operating expenses |
4,444 | 1,593 | 9,948 | 4,274 | 18,226 | |||||||||||||||
Depreciation and amortization |
221 | 159 | 625 | 456 | 1,370 | |||||||||||||||
Total operating expenses |
7,117 | 3,060 | 16,896 | 8,724 | 32,653 | |||||||||||||||
Loss from operations |
(6,756 | ) | (3,019 | ) | (16,102 | ) | (8,611 | ) | (31,592 | ) | ||||||||||
Interest income |
152 | 39 | 487 | 116 | 699 | |||||||||||||||
Loss before provision for income taxes |
(6,604 | ) | (2,980 | ) | (15,615 | ) | (8,495 | ) | (30,893 | ) | ||||||||||
Provision for income taxes |
| | | 2 | 1 | |||||||||||||||
Net loss |
$ | (6,604 | ) | $ | (2,980 | ) | $ | (15,615 | ) | $ | (8,497 | ) | $ | (30,894 | ) | |||||
Basic and diluted net loss per share |
$ | (0.22 | ) | $ | (0.12 | ) | $ | (0.52 | ) | $ | (0.35 | ) | ||||||||
See accompanying notes to financial statements.
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Hythiam, Inc. and Subsidiaries
(a Development Stage Company)
(a Development Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
Period from | ||||||||||||
Nine Months Ended | February 13, 2003 | |||||||||||
September 30, | (Inception) to | |||||||||||
(In thousands) | 2005 | 2004 | September 30, 2005 | |||||||||
Operating activities |
||||||||||||
Net loss |
$ | (15,615 | ) | $ | (8,497 | ) | $ | (30,894 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||||
Depreciation and amortization |
625 | 456 | 1,370 | |||||||||
Provision for bad debt |
10 | | 10 | |||||||||
Loss on disposition of fixed assets |
20 | | 20 | |||||||||
Deferred rent liability amortization |
32 | 22 | 79 | |||||||||
Share-based expense |
1,648 | 682 | 3,165 | |||||||||
Changes in current assets and liabilities: |
||||||||||||
Receivables |
(69 | ) | 99 | (237 | ) | |||||||
Prepaids and other current assets |
(279 | ) | (48 | ) | (527 | ) | ||||||
Accounts payable |
1,393 | (819 | ) | 2,002 | ||||||||
Accrued compensation and benefits |
(39 | ) | 566 | 787 | ||||||||
Other accrued liabilities |
(147 | ) | (245 | ) | 182 | |||||||
Net cash used in operating activities |
(12,421 | ) | (7,784 | ) | (24,043 | ) | ||||||
Investing activities |
||||||||||||
Purchases of marketable securities |
(8,091 | ) | (10,819 | ) | (58,245 | ) | ||||||
Proceeds from sales and maturities of marketable securities |
21,414 | 16,000 | 48,089 | |||||||||
Purchases of property and equipment |
(699 | ) | (378 | ) | (3,648 | ) | ||||||
Deposits made on property and equipment |
(143 | ) | | (143 | ) | |||||||
Reimbursement received on tenant improvement costs |
30 | 301 | 331 | |||||||||
Deposit made on intellectual property amendment |
| (75 | ) | | ||||||||
Proceeds from maturity of deposit as collateral for letter of credit |
355 | 352 | 707 | |||||||||
Cash deposited as collateral |
(802 | ) | (350 | ) | (1,502 | ) | ||||||
Cost of intellectual property |
(137 | ) | (3 | ) | (801 | ) | ||||||
Increase in restricted cash and marketable securities |
(65 | ) | | (65 | ) | |||||||
Net cash provided by (used in) investing activities |
11,862 | 5,028 | (15,277 | ) | ||||||||
Financing activities |
||||||||||||
Net proceeds from sales of common and preferred stock and warrants |
| | 42,694 | |||||||||
Costs incurred on equity financing activities |
(194 | ) | | (194 | ) | |||||||
Proceeds from exercise of warrants |
203 | 36 | 270 | |||||||||
Net cash provided by financing activities |
9 | 36 | 42,770 | |||||||||
Net (decrease) increase in cash and cash equivalents |
(550 | ) | (2,720 | ) | 3,450 | |||||||
Cash and cash equivalents at beginning of period |
4,000 | 3,444 | | |||||||||
Cash and cash equivalents at end of period |
$ | 3,450 | $ | 724 | $ | 3,450 | ||||||
Supplemental disclosure of cash paid |
||||||||||||
Income taxes |
$ | | $ | 3 | $ | 3 | ||||||
Supplemental disclosure of non-cash activity |
||||||||||||
Common stock and warrants issued for intellectual property |
$ | | $ | | $ | 2,634 | ||||||
Common stock, options and warrants issued for outside services |
230 | 86 | 1,720 | |||||||||
Common stock and warrants issued as commissions on private placement |
| | 265 |
See accompanying notes to financial statements.
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Hythiam, Inc. and Subsidiaries
Notes to Condensed Consolidated Financial Statements
Note 1. Basis of Presentation
The accompanying unaudited interim condensed consolidated financial statements for Hythiam,
Inc. and its subsidiaries have been prepared in accordance with the Securities and Exchange
Commission (SEC) rules for interim financial information and do not include all information and
notes required for complete financial statements. In the opinion of management, all adjustments,
consisting of normal recurring accruals, considered necessary for a fair presentation have been
included. Interim results are not necessarily indicative of the results that may be expected for
the entire fiscal year. The accompanying financial information should be read in conjunction with
the financial statements and the notes thereto in our most recent Annual Report on Form 10-K. The
December 31, 2004 balance sheet has been derived from the audited financial statements on Form
10-K. Certain reclassifications have been made to the prior years condensed consolidated
financial statements to conform to classifications used in the current year. All share data has
been restated to reflect stock splits.
We are considered a development stage company since most of our efforts to date have been
devoted to raising capital, recruiting management and developing markets, and revenues earned to
date from operations have not been significant.
Note 2. Cash Equivalents and Marketable Securities
We invest available cash in short-term commercial paper, certificates of deposit and high
grade variable rate securities. Liquid investments with an original maturity of three months or
less when purchased are considered to be cash equivalents.
Investments, including auction rate securities and certificates of deposit, with maturity
dates greater than three months when purchased which have readily determined fair values are
classified as available-for-sale investments and reflected in current assets as marketable
securities at fair market value. Auction rate securities are recorded at par value, which equals
fair market value, as the rate on such securities resets generally every 7, 28 or 35 days.
Restricted cash and marketable securities represents deposits secured as collateral for a bank
credit card program.
Note 3. Basic and Diluted Loss per Share
In accordance with Statement of Financial Accounting Standards (SFAS) 128, Computation of
Earnings Per Share, basic loss per share is computed by dividing the net loss to common
stockholders for the period by the weighted average number of common shares outstanding during the
period. Diluted loss per share is computed by dividing the net loss for the period by the weighted
average number of common and dilutive common equivalent shares outstanding during the period.
Common equivalent shares, consisting of 6,906,000 and 6,243,000 of incremental common shares
as of September 30, 2005 and 2004, respectively, issuable upon the exercise of stock options and
warrants have been excluded from the diluted earnings per share calculation because their effect is
anti-dilutive.
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A summary of the net loss and shares used to compute net loss per share is as follows (in
thousands, except per share data):
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2005 | 2004 | 2005 | 2004 | |||||||||||||
Net loss |
$ | (6,604 | ) | $ | (2,980 | ) | $ | (15,615 | ) | $ | (8,497 | ) | ||||
Basic and diluted loss per share |
$ | (0.22 | ) | $ | (0.12 | ) | $ | (0.52 | ) | $ | (0.35 | ) | ||||
Weighted average common shares
used to compute basic and diluted
loss per share |
29,867 | 24,624 | 29,806 | 24,617 | ||||||||||||
Note 4. Share-Based Compensation
Stock options
Under our 2003 Stock Incentive Plan, we have granted options to employees and directors as
well as to non-employees for outside consulting services.
We account for the issuance of employee stock options using the intrinsic value method under
Accounting Principles Board Opinion No. 25 (APB 25), Accounting for Stock Issued to Employees.
Had we determined compensation cost based on the fair value at the grant date for our employee
stock options under SFAS 123, Accounting for Stock-Based Compensation, the pro forma effect on
net loss and net loss per share would have been as follows (in thousands, except per share data):
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||||
2005 | 2004 | 2005 | 2004 | |||||||||||||
Net loss, as reported |
$ | (6,604 | ) | $ | (2,980 | ) | $ | (15,615 | ) | $ | (8,497 | ) | ||||
Less: Share-based expense
determined under fair value based
method |
(256 | ) | (143 | ) | (624 | ) | (380 | ) | ||||||||
Pro forma net loss |
$ | (6,860 | ) | $ | (3,123 | ) | $ | (16,239 | ) | $ | (8,877 | ) | ||||
Net loss per share |
||||||||||||||||
As reported basic and diluted |
$ | (0.22 | ) | $ | (0.12 | ) | $ | (0.52 | ) | $ | (0.35 | ) | ||||
Pro forma basic and diluted |
$ | (0.23 | ) | $ | (0.13 | ) | $ | (0.54 | ) | $ | (0.36 | ) |
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The fair value of the options was estimated at the date of grant using the Black-Scholes
pricing model with the following weighted average assumptions for the three and nine months ended
September 30, 2005 and 2004:
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2005 | 2004 | 2005 | 2004 | |||||||||||||
Expected volatility |
63 | % | 61 | % | 63 | % | 61 | % | ||||||||
Risk-free interest rate |
4.17 | % | 4.48 | % | 4.18 | % | 4.24 | % | ||||||||
Weighted average expected lives in
years |
10 | 10 | 10 | 10 | ||||||||||||
Expected dividend yield |
0 | % | 0 | % | 0 | % | 0 | % |
During the three and nine months ended September 30, 2005 and the three and nine months
ended September 30, 2004, we granted options for 397,000, 1,317,000, 652,000 and 1,220,000 shares,
respectively, to employees and directors at the weighted average per share exercise price of
$5.86, $6.49, $2.80 and $4.24, respectively, the fair market values at the dates of grant.
Subsequently, in October 2005 we granted options for 50,000 shares to a consultant at $5.40 per
share, the fair market value at date of grant.
As of September 30, 2005, options for 445,000, shares granted to consultants and directors
accounted for under SFAS 123 were outstanding. These options vest over periods ranging from three
to four years and are being charged to expense as services are provided using the variable
accounting method. Non-vested options have an estimated fair value of approximately $938,000, as
of September 30, 2005, using the Black-Scholes pricing model.
During the three and nine months ended September 30, 2005 and 2004, share-based expense
relating to stock options amounted to $272,000, $1.2 million, $320,000 and $320,000, respectively.
Warrants
We account for the issuance of warrants for services from non-employees in accordance with
SFAS 123, by estimating the fair value of warrants issued using the Black-Scholes pricing model.
If warrants issued as compensation to non-employees for services are fully vested and
non-forfeitable at the time of issuance, the estimated value is recorded in equity and expensed
when the services are performed and benefit is received as provided by Financial Accounting
Standards Board Emerging Issues Task Force No. 96-18. If warrants are issued for consideration in
an acquisition of assets, the value of the warrants are recorded in equity at the time of issuance
and included in the purchase price to be allocated.
During the nine months ended September 30, 2005, we issued a warrant to purchase 25,000 shares
of common stock at $5.72 per share to a management advisor for investor relations services. The
warrant vested immediately and expires three years from date of grant. We also issued warrants to
purchase 20,000 shares of common stock to a management consultant, of which a warrant for 10,000
shares was issued at $2.80 per share, with immediate vesting and expires in 2014, and a warrant for
the remaining 10,000 shares was issued at $5.80 per share, with immediate vesting and expires in
2006. The total estimated fair value of warrants issued in the nine months ended September 30,
2005 is approximately $104,000 using the Black-Scholes pricing model.
During the three and nine months ended September 30, 2005 and 2004, share-based expense
relating to warrants amounted to $48,000, $336,000, $40,000 and $287,000, respectively.
Common Stock
In March 2005 we issued 11,700 shares of common stock and in July 2005 we issued an additional
11,700 shares of common stock to a consultant providing investor relation services. The common
stock, which is being amortized to expense on a straight-line basis over a 12 month service period, was valued at $65,000 and $69,000,
respectively, the fair market values at the dates of grant.
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Share-based expense relating to stock issued for outside services was $35,000, $99,000,
$11,000 and $76,000, for the three and nine months ended September 30, 2005 and 2004, respectively.
Note 5. Recent Accounting Pronouncements
In December 2004, the Financial Accounting Standards Board (FASB) issued SFAS 123(R),
Share-Based Payment, which addresses the accounting for employee stock options. SFAS 123(R)
revises the disclosure provisions of SFAS 123 and supersedes APB 25. SFAS 123(R) requires that
the cost of all employee stock options, as well as other equity-based compensation arrangements, be
reflected in the financial statements based on the estimated fair value of the awards. In March
2005, the Securities & Exchange Commission (the SEC) issued Staff Accounting Bulletin No. 107,
Share-Based Payment, which summarizes the views of the SEC staff regarding the interaction
between SFAS 123(R) and certain SEC rules and regulations, and is intended to assist in the initial
implementation. SFAS 123(R) is effective for all public companies that file as of the
beginning of the first interim or annual reporting period that begins after June 15, 2005.
However, in April 2005, the SEC announced that it would permit companies to implement this
statement at the beginning of their next fiscal year. We are currently evaluating the provisions
of SFAS 123(R) and its effect on our financial statements. The effect of adopting this statement
will be to increase our compensation expense in the future.
In December 2004, the FASB issued SFAS 153, Exchanges of Nonmonetary Assets, an amendment of
APB 29, Accounting for Nonmonetary Transactions. This Statements amendments are based on the
principle that exchanges of nonmonetary assets should be measured based on the fair value of the
assets exchanged. Further, SFAS 153 eliminates the narrow exception for nonmonetary exchanges of
similar productive assets and replaces it with a broader exception for exchanges of nonmonetary
assets that do not have commercial substance. Provisions of this statement are effective for fiscal
periods beginning after June 15, 2005. We do not expect the adoption of this statement to have a
material impact on our financial statements.
In March 2005, the FASB issued FASB Interpretation No. 47, Accounting for Conditional Asset
Retirement Obligations (FIN 47), which is an interpretation of SFAS 143, Accounting for Asset
Retirement Obligations. FIN47 clarifies terminology within SFAS 143 and requires an entity to
recognize a liability for the fair value of a conditional asset retirement obligation when incurred
if the liabilitys fair value can be reasonably estimated. FIN 47 is effective for fiscal years
ending after December 15, 2005. We do not expect the adoption of this statement to have a material
impact on our financial statements.
In May 2005, the FASB issued SFAS 154, Accounting Changes and Error Corrections. SFAS 154
replaces APB 20, Accounting Changes and SFAS 3, Reporting Accounting Changes in Interim Financial
Statements and establishes retrospective application as the required method for reporting a change
in accounting principle. SFAS 154 provides guidance for determining whether retrospective
application of a change in accounting principle is impracticable and for reporting a change when
retrospective application is impracticable. The reporting of a correction of an error by restating
previously issued financial statements is also addressed. SFAS 154 is effective for accounting
changes and corrections of errors made in fiscal years beginning after December 15, 2005. We do
not expect the adoption of this statement to have a material impact on our financial statements.
Note 6. Subsequent Event
On November 8, 2005 we completed the sale of 8.0 million shares in an underwritten follow-on
offering of our common stock at a public offering price of $4.75 per share. We received
approximately $35 million in net proceeds from the offering, after underwriting discounts,
commissions and transaction costs. In addition, we granted the underwriters a 30-day option to
purchase up to 1.2 million additional shares of common stock to cover over-allotments, if any.
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ITEM 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
The following discussion of our financial condition and results of operations should be read
in conjunction with our financial statements and the related notes, and the other financial
information included in this report.
Forward-Looking Statements
The forward-looking comments contained in this report involve risks and uncertainties. Our
actual results may differ materially from those discussed here due to factors such as, among
others, limited operating history, difficulty in developing, exploiting and protecting proprietary
technologies, intense competition and substantial regulation in the healthcare industry.
Additional factors that could cause or contribute to such differences can be found in the following
discussion, as well as in the Risks Factors set forth in Item 1 of Part I of our Annual Report on
Form 10-K filed with the Securities and Exchange Commission on March 31, 2005.
Overview
Hythiam, Inc. is a healthcare services management company, focused on delivering alcohol and
drug dependence solutions. We research, develop, license and commercialize innovative physiological
treatment protocols designed for use by healthcare providers seeking to treat individuals diagnosed
with dependencies to alcohol, cocaine and methamphetamine, as well as combinations of these drugs.
Unlike traditional treatment methodologies, our proprietary PROMETA treatment protocols include
medically supervised treatments designed to address both the neurochemical imbalances in the brain
and some of the nutritional deficits caused or worsened by substance dependence. Changes in brain
chemistry and function play an important role in the physical and behavioral symptoms of substance
dependence, including tolerance, withdrawal symptoms, craving and relapse. PROMETA represents an
innovative approach to managing substance dependence that is designed to address physiological,
nutritional and psychosocial aspects of the disease, and is thereby intended to offer patients an
opportunity to achieve sustained recovery.
We generate revenues by charging fees to licensed healthcare providers for access to our
proprietary protocols for use in treating their patients. We also provide administrative services
to assist physicians and facilities with staff education, marketing and sales support, and outcomes
tracking for data analysis.
In the first nine months of 2005, we entered into 16 new licensing agreements, bringing the
total number of licensees to 23 at September 30, 2005. In the same period 152 patients were treated
using our Prometa protocols. We expanded our corporate office space during the second quarter to
accommodate our increasing staff and have leased and are building out medical office space that
will be occupied by a medical group to which we have agreed to provide turn-key business management
services and a license to use our protocol beginning in the fourth quarter of this year, in
exchange for management and licensing fees.
In the first nine months of 2005, we have announced a number of clinical studies by preeminent
researchers in the field of substance dependence, and we are currently in the process of awarding
additional grants to investigators to test the efficacy of the Prometa protocol through the conduct
of double-blind, placebo controlled studies as well as open label studies for alcohol and
methamphetamine dependence. We have also announced that a drug court in Indiana will evaluate the
use of the Prometa protocols for drug court participants in a pilot endorsed by the National
Association of Drug Court Professionals.
We established several wholly-owned foreign subsidiaries for the purpose of licensing our
intellectual property in foreign markets, and entered into an agreement to acquire protocols for
the treatment of nicotine and drug dependence in Europe. Although we have not commenced any
significant foreign operations to date, we are planning to open several clinics in Europe for the
treatment of smoking cessation in the fourth quarter of 2005.
Results of Operations
We have a limited history of operations, have not yet commenced substantial marketing
activities, and have not generated significant revenues from operations. Our revenues are
generated from fees that we charge to hospitals, healthcare facilities and other healthcare
providers that license our Prometa protocols. Our license agreements provide for a fee for the
licensed technology and related services, set on a per-patient basis, and thus our revenues are
generally related to the number of patients treated. Key indicators of our financial performance
will be the number of facilities
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and healthcare providers that contract with us to license our technology and the number of patients
that are treated by those providers using our Prometa protocols. We believe that the number of
patients treated by our licensees will increase over time as our marketing, advertising and
branding activities are implemented and clinical outcomes data from research studies become
available.
Revenues
Our revenues for the three and nine month periods ended September 30, 2005 were $361,000 and
$794,000, respectively, compared to $41,000 and $113,000 in the comparable periods last year. The
increase in revenues was driven by licensing fees earned from healthcare sites which completed
treatment of a total of 72 and 152 patients for the three and nine months. By the end of the third
quarter of 2005, there were 11 operational licensee sites contributing to revenues at some level,
compared to just one operational site in the same period last year. In the third quarter of 2005,
we entered into five new licensing agreements with hospitals and healthcare providers, bringing the
total number of licensees to 23 at September 30, 2005. During the first nine months of 2005, 152
patients were treated using our Prometa protocols, compared to 25 patients in the same period last
year. As we look forward to the fourth quarter, we now have 25 contracted licensees, of which 15 to
20 should be operational and contributing towards revenues by the end of the quarter. As we deploy
our new Prometa brand identity and accelerate local marketing activity, we should see a continued
increase in patient traffic toward the end of this calendar year and into 2006. However, until
each of the licensed treatment centers becomes fully operational and local marketing programs are
in place to increase public awareness, we do not expect a significant increase in patient activity
in the fourth quarter of 2005. Thus far, new sites have typically started generating revenues after
an initial four to six-month training and start-up period following contract signing.
Pre-operational site initiation activities include the hiring and training of a local site manager,
the education and training of the licensee physicians and staff in the Prometa protocols, the
development of a local marketing plan and the mutual approval by both parties in the implementation
plan for site launch.
Our license agreements provide for a fee for the licensed technology and related services, set
on a per patient basis, and thus our revenues are generally related to the number of patients
treated. Key indicators of our financial performance in the future will be the number of
facilities and healthcare providers that contract with us to license our proprietary protocols and
the number of patients that are treated by those providers using the Prometa protocols.
Expenses
We have devoted a substantial portion of our financial resources to the payment of salaries
and benefits, legal and professional services, and other general and administrative expenses during
our start-up period.
Our operating expenses during the three and nine month periods ended September 30, 2005 were
$7.1 million and $16.9 million, respectively, compared to $3.1 million and $8.7 million,
respectively, for the same periods last year. The increase in operating expenses in 2005 over 2004
reflects the continued development of our company and the execution of our business plan, including
a national and international expansion strategy, hiring of key management personnel, investing in
clinical research and the marketing of our Prometa protocols.
Salaries and benefits expenses were $2.5 million and $6.3 million for the three and nine month
periods ended September 30, 2005, compared to $1.3 million and $4.0 million for the same periods in 2004. The
increase for both periods was due to increased staffing to serve our growing number of licensees as
well as the strengthening of our executive management team to implement our business plan.
In the three and nine month periods ended September 30, 2005, our other operating expenses
were $4.4 million and $9.9 million, respectively, versus $1.6 million and $4.3 million,
respectively, last year, including non-cash charges of $355,000, $1.6 million, $371,000 and
$682,000, respectively, relating to share-based expense. Other operating expenses payable in cash
for the three and nine months ended September 30, 2005 were $4.1 million and $8.3 million,
respectively, compared to $1.2 million and $3.6 million, respectively, for the same periods last
year. Major components of our other operating expenses include legal, audit, insurance, travel and
entertainment, rent, investor and public relations, clinical research, marketing, and other
professional consulting costs. The increases in 2005 over the comparable periods in 2004 in most
expense categories are generally proportionate to the overall increase in staffing and
infrastructure of our company, with additional spending in 2005 for clinical research studies,
legal and consulting costs for international expansion, accounting and consulting costs for
Sarbanes-Oxley compliance and new marketing and business development activities.
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As of September 30, 2005, we have substantially completed the hiring of our senior management
team and a substantial portion of our corporate management and supporting staff. As we enter into
new licensing agreements, we will continue to hire additional site managers and supporting
operational staff. Accordingly, our salaries, benefits and travel related expenses will continue
to increase with the growth in our business. Additionally, we are planning to significantly
increase our marketing efforts in the fourth quarter of 2005 to provide for local marketing and
advertising as well as brand awareness on both a local and national level. We will also allocate
up to $1.5 million in the fourth quarter of 2005 towards clinical studies and our patient outcomes
registry.
Research Studies and Pilot Programs
We have announced a number of clinical studies by preeminent researchers in the field of
substance dependence, and we are currently in the process of awarding additional grants to
investigators to test the efficacy of the Prometa protocol through the conduct of double-blind,
placebo controlled studies as well as open label studies for alcohol and methamphetamine
dependence. In the second quarter, we signed two contracts with independent researchers to provide
unrestricted grants for the study of the Prometa protocol: one for a randomized, controlled study
comparing our Prometa protocols to standard medical treatment for alcohol dependence, and the
second for a controlled study to investigate our Prometa protocols for the treatment of
methamphetamine dependence. In the third quarter we announced that the University of California,
Los Angeles will conduct a multi-site, double-blind placebo controlled study on the Prometa
treatment protocol for methamphetamine dependence. In October, 2005, we signed a contract with the
Medical University of South Carolina for an unrestricted grant to conduct a double-blind, placebo
controlled clinical study of the Prometa treatment protocol for alcoholism.
In the third quarter, a drug court in Indiana announced it will evaluate the use of the
Prometa protocols for drug court participants in a pilot endorsed by the National Association of
Drug Court Professionals.
In addition, we have initiated a patient outcomes registry to be conducted by a Contract
Research Organization to monitor and evaluate outcomes of approximately 750 patients undergoing
treatment using the Prometa protocol at our commercial licensee sites
Prometa Center
In the fourth quarter 2005, we are planning to commence management for a medical practice that
will occupy medical office space provided by us and license our Prometa protocols for the treatment of
individuals diagnosed with dependencies to alcohol, cocaine and methamphetamine. The medical practice is
located in Santa Monica, California. We are currently building out the leased space at an
estimated total cost of approximately $1.1 million, including tenant improvements, furniture and
medical and office equipment. Our management and licensing agreements will provide turn-key business management
services to the medical group in exchange for management and licensing fees.
International Operations
In June 2005, we and our international subsidiary Hythiam International (Cayman) Ltd. entered
into an asset purchase agreement to obtain the worldwide rights to trade secret protocols for the
treatment of nicotine and drug dependence, in exchange for a percentage of future net profits from
exploitation of the protocols. In addition, as part of our European expansion strategy, we have
incorporated several wholly owned foreign subsidiaries and have engaged consultants to explore
opportunities to start up clinic operations for the treatment of nicotine dependence in Europe. As
of September 30, 2005, we had not begun any significant international operations. We are currently
evaluating the market opportunity and preparing to open clinics in Europe for the treatment of
smoking cessation in the future.
Liquidity and Capital Resources
We have financed our operations since inception primarily through the sale of shares of our
stock. At September 30, 2005 we had approximately $14 million in cash, cash equivalents and
marketable securities. In November 2005, we raised an additional $35 million in net proceeds from
a follow-on underwritten offering of 8.0 million shares of our common stock. In addition, we have
granted to the underwriters a 30-day option to purchase an additional 1.2 million shares to cover
over-allotments, if any.
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Since we are a developing business, both our current and prior operating costs are not
representative of our expected future costs. As we continue to implement commercial operations and
allocate significant and increasing resources to business development, hire additional personnel,
expand our market and engage in other start-up activities, we expect our cash operating expenses in
the fourth quarter of 2005 to increase from our current average of approximately $2.2 million per
month as we enter into additional licensing agreements and increase our marketing efforts to
provide for local marketing and advertising as well as brand awareness on both a local and national
level. As of October 31, 2005, we have remaining commitments of approximately $4.3 million to
provide funding for unrestricted grants for research studies for our Prometa protocol. In
addition, we have initiated a patient outcomes registry to be conducted by a Contract Research
Organization to monitor and evaluate outcomes of approximately 750 patients undergoing treatment
using the Prometa protocol at our commercial licensee sites. The combined cost of the studies and
patient registry is estimated at approximately $8 million over the next two years.
In April 2005, we signed a five year lease for medical office space in Santa Monica,
California, at an initial base rent of $19,000 per month commencing in August 2005. We estimate our
total build-out costs for tenant improvements, furniture and equipment will be approximately $1.1
million. We plan to provide use of this space to a medical group for whom we have agreed to provide
turn-key business management services and a license to use our protocol beginning in the fourth
quarter of this year in exchange for a management and licensing fee.
We continue to invest in the infrastructure we believe we will need, both in management as
well as systems and equipment, to develop, market and implement our business plan. Our future
capital requirements will depend upon many factors, including costs associated with the
effectiveness of marketing our protocols, obtaining regulatory approvals and preparing, filing,
prosecuting, maintaining and enforcing patent claims and other proprietary rights. Additionally,
our future expenditures will depend on competing technological and market developments and our
ability to establish collaborative arrangements, effective commercialization, marketing activities
and other arrangements.
We expect to continue to incur negative cash flows and net losses for at least the next twelve
months. Based upon our current business plan, we believe that our
existing cash reserves plus the $35 million in net proceeds from the completion of our recent stock offering in November will be sufficient to
meet our operating expenses and capital requirements until we achieve profitability. However,
changes in our business strategy, technology development or marketing plans or other events
affecting our operating plans and expenses may result in the expenditure of existing cash before
that time. If this occurs, our ability to meet our cash obligations as they become due and payable
will depend on our ability to sell securities, borrow funds or some combination thereof. We may
seek additional funding through public or private financing or through collaborative arrangements
with strategic partners. We may also seek to raise additional capital through public or private
financing in order to increase the amount of our cash reserves on hand. We may not be successful in
raising necessary funds on acceptable terms, or at all.
Contractual Obligations and Commercial Commitments
The following table sets forth a pro forma summary of our material minimum contractual
obligations and commercial commitments as of September 30, 2005 (in thousands):
Less than 1 | More than 5 | |||||||||||||||||||
Contractual Obligations | Total | year | 1 - 3 years | 3 - 5 years | years | |||||||||||||||
Operating lease obligations (1) |
$ | 4,214 | $ | 777 | $ | 1,624 | $ | 1,686 | $ | 127 | ||||||||||
Contractual commitments for clinical studies (2) |
1,287 | 716 | 571 | | | |||||||||||||||
$ | 5,501 | $ | 1,493 | $ | 2,195 | $ | 1,686 | $ | 127 | |||||||||||
(1) | Consists of our current lease obligations for our corporate office and a medical office. | |
(2) | Subsequent to September 30, 2005, entered into additional commitments of $3.9 million over a two-year period. |
Off-Balance Sheet Arrangements
As of September 30, 2005 we had no off-balance sheet arrangements.
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Critical Accounting Policies and Estimates
The discussion and analysis of our financial condition and results of operations is based upon
our financial statements, which have been prepared in accordance with accounting principles
generally accepted in the United States. Generally accepted accounting principles require
management to make estimates, judgments and assumptions that affect the reported amounts of assets,
liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities. We
base our estimates on experience and on various other assumptions that we believe to be reasonable
under the circumstances, the results of which form the basis for making judgments about the
carrying values of assets and liabilities that may not be readily apparent from other sources. Our
actual results may differ from those estimates.
We consider our critical accounting policies to be those that involve significant
uncertainties, require judgments or estimates that are more difficult for management to determine
or that may produce materially different results when using different assumptions. We consider the
following accounting policies to be critical:
Revenue recognition
Our revenues are derived from licensing our treatment protocols and providing administrative
services to hospitals, treatment facilities and other healthcare providers. We determine revenues
earned based on the terms of these contracts, which determination requires the use of judgment,
including the assessment of the collectibility of receivables. Licensing agreements typically
provide for a fixed fee on a per-patient basis, payable to us upon commencement of the patients
initial treatment using our protocol. For revenue recognition purposes, we treat the protocol
licensing and related administrative services as one unit of accounting. We record the fees owed
to us under the terms of the agreements at the time we have performed substantially all required
services for each patients treatment, which for substantially all of our license agreements is in
the period in which the patients medically supervised treatment has commenced, and, in other
cases, is at the time the initial medical treatment has been completed.
Share-based expense
We account for the issuance of options and warrants for services from non-employees in
accordance with SFAS 123, Accounting for Stock-Based Compensation, by estimating the fair value
of options and warrants issued using the Black-Scholes pricing model. This models calculations
include the exercise price, the market price of shares on grant date, weighted average assumptions
for risk-free interest rates, expected life of the option or warrant, expected volatility of our
stock and expected dividend yield. The amounts recorded in the financial statements for
share-based expense could vary significantly if we were to use different assumptions.
Impairment of intangible assets
We have capitalized significant costs, and plan to capitalize additional costs, for acquiring
patents and other intellectual property directly related to our products and services. We will
continue to evaluate our intangible assets for impairment on an ongoing basis by assessing the
future recoverability of such capitalized costs based on estimates of our future revenues less
estimated costs. Since we are a development stage company and have not recognized significant
revenues to date, our estimates of future revenues may not be realized and the net realizable value
of our capitalized costs of intellectual property may become impaired.
Our accounting policies are more fully described in Note 1 to our audited financial statements
included in our Annual Report on Form 10-K for the year ended December 31, 2004.
Recent Accounting Pronouncements
In December 2004, the Financial Accounting Standards Board (FASB) issued SFAS 123(R),
Share-Based Payment, which addresses the accounting for employee stock options. SFAS 123(R)
revises the disclosure provisions of SFAS 123 and supersedes APB 25. SFAS 123(R) requires that
the cost of all employee stock options, as well as other equity-based compensation arrangements, be
reflected in the financial statements based on the estimated fair value of the awards. In March
2005, the Securities & Exchange Commission (the SEC) issued Staff Accounting Bulletin No. 107,
Share-Based Payment, which summarizes the views of the SEC staff regarding the interaction
between SFAS 123(R) and certain SEC rules and regulations, and is intended to assist in the initial
implementation. SFAS 123(R) is effective for all public companies that file as of the
beginning of the first interim or annual reporting
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period that begins after June 15, 2005.
However, in April 2005, the SEC announced that it would permit companies to implement this
statement at the beginning of their next fiscal year. We are currently evaluating the provisions
of SFAS 123(R) and its effect on our financial statements. The effect of adopting this statement
will be to increase our compensation expense in the future.
In December 2004, the FASB issued SFAS 153, Exchanges of Nonmonetary Assets, an amendment of
APB 29, Accounting for Nonmonetary Transactions. This Statements amendments are based on the
principle that exchanges of nonmonetary assets should be measured based on the fair value of the
assets exchanged. Further, SFAS 153 eliminates the narrow exception for nonmonetary exchanges of
similar productive assets and replaces it with a broader exception for exchanges of nonmonetary
assets that do not have commercial substance. Provisions of this statement are effective for fiscal
periods beginning after June 15, 2005. We do not expect the adoption of this statement to have a
material impact on our financial statements.
In March 2005, the FASB issued FASB Interpretation No. 47, Accounting for Conditional Asset
Retirement Obligations (FIN 47), which is an interpretation of SFAS 143, Accounting for Asset
Retirement Obligations. FIN 47 clarifies terminology within SFAS 143 and requires an entity to
recognize a liability for the fair value of a conditional asset retirement obligation when incurred
if the liabilitys fair value can be reasonably estimated. FIN 47 is effective for fiscal years
ending after December 15, 2005. We do not expect the adoption of this statement to have a material
impact on our financial statements.
In May 2005, the FASB issued SFAS 154, Accounting Changes and Error Corrections. SFAS 154
replaces APB 20, Accounting Changes and SFAS 3, Reporting Accounting Changes in Interim Financial
Statements and establishes retrospective application as the required method for reporting a change
in accounting principle. SFAS 154 provides guidance for determining whether retrospective
application of a change in accounting principle is impracticable and for reporting a change when
retrospective application is impracticable. The reporting of a correction of an error by restating
previously issued financial statements is also addressed. SFAS 154 is effective for accounting
changes and corrections of errors made in fiscal years beginning after December 15, 2005. We do
not expect the adoption of this statement to have a material impact on our financial statements.
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk
We invest our cash in short term commercial paper, certificates of deposit, money market
accounts and marketable securities. We consider any liquid investment with an original maturity of
three months or less when purchased to be cash equivalents. We classify investments with maturity
dates greater than three months when purchased as marketable securities, which have readily
determined fair values as available-for-sale securities. Our investment policy requires that all
investments be investment grade quality and no more than ten percent of our portfolio may be
invested in any one security or with one institution. At September 30, 2005, our investment
portfolio consisted of investments in highly liquid, high grade commercial paper, variable rate
securities and certificates of deposit. The weighted average interest rate of cash equivalents and
marketable securities held at September 30, 2005 was 3.75%.
Investments in both fixed rate and floating rate interest earning instruments carry a degree
of interest rate risk. Fixed rate securities may have their fair market value adversely impacted
due to a rise in interest rates, while floating
rate securities with shorter maturities may produce less income if interest rates fall. The
market risk associated with our investments in debt securities is substantially mitigated by the
frequent turnover of the portfolio.
ITEM 4. Controls and Procedures
We have evaluated, with the participation of our Chief Executive Officer and our Chief
Financial Officer, the effectiveness of our system of disclosure controls and procedures as of the
end of the period covered by this report. Based on this evaluation our Chief Executive Officer and
our Chief Financial Officer have determined that they are effective in connection with the
preparation of this report. There were no changes in the internal controls over
financial reporting that occurred during the quarter ended September 30, 2005 that have materially
affected, or are reasonably likely to materially affect, our internal control over financial
reporting.
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PART II OTHER INFORMATION
ITEM 1. Legal Proceedings
From time to time, we may be involved in litigation relating to claims arising out of our
operations in the normal course of business. As of the date of this filing, we are not currently
involved in any legal proceeding that we believe would have a material adverse effect on our
business, financial condition or operating results.
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds
Not Applicable.
ITEM 3. Defaults Upon Senior Securities
Not Applicable.
ITEM
4. Submission of Matters to a Vote of Security Holders
Not Applicable.
ITEM 5. Other Information.
CAUTIONARY STATEMENT CONCERNING FORWARD-LOOKING INFORMATION
This report contains forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995 with respect to the financial condition, results of operations,
business strategies, operating efficiencies or synergies, competitive positions, growth
opportunities for existing products, plans and objectives of management, markets for stock of
Hythiam and other matters. Statements in this report that are not historical facts are hereby
identified as forward-looking statements for the purpose of the safe harbor provided by Section
21E of the Exchange Act and Section 27A of the Securities Act. Such forward-looking statements,
including, without limitation, those relating to the future business prospects, revenues and income
of Hythiam, wherever they occur, are necessarily estimates reflecting the best judgment of the
senior management of Hythiam on the date on which they were made, or if no date is stated, as of
the date of this report. These forward-looking statements are subject to risks, uncertainties and
assumptions, including those described in the Risk Factors in Item 1 of Part I of our most recent
Annual Report on Form 10-K filed with the SEC, that may affect the operations, performance,
development and results of our business. Because the factors discussed in this report could cause
actual results or outcomes to differ materially from those expressed in any forward-looking
statements made by us or on our behalf, you should not place undue reliance on any such
forward-looking statements. New factors emerge from time to time, and it is not possible for us to
predict which factors will arise. In addition, we cannot assess the impact of each factor on our
business or the extent to which any factor, or combination of factors, may cause actual results to
differ materially from those contained in any forward-looking statements.
You should understand that the following important factors, in addition to those discussed
above and in the Risk Factors could affect our future results and could cause those results to
differ materially from those expressed in such forward-looking statements:
| the anticipated results of clinical studies on the efficacy of our protocols, and the publication of those results in medical journals | ||
| plans to have our protocols approved for reimbursement by third-party payors | ||
| plans to license our protocols to more hospitals and healthcare providers | ||
| marketing plans to raise awareness of our PROMETA protocols |
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| anticipated trends and conditions in the industry in which we operate, including regulatory changes | ||
| our future operating results, capital needs, and ability to obtain financing |
We undertake no obligation to publicly update or revise any forward-looking statements,
whether as a result of new information, future events or any other reason. All subsequent
forward-looking statements attributable to the Company or any person acting on our behalf are
expressly qualified in their entirety by the cautionary statements contained or referred to herein.
In light of these risks, uncertainties and assumptions, the forward-looking events discussed in
this report may not occur.
ITEM 6. Exhibits
Exhibit 31.1
|
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | ||
Exhibit 31.2
|
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | ||
Exhibit 32.1
|
Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | ||
Exhibit 32.2
|
Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
HYTHIAM, INC. | ||||||
Date: November 14, 2005
|
By: | /S/ TERREN S. PEIZER
|
||||
President and Chief Executive Officer | ||||||
Date: November 14, 2005
|
By: | /S/ CHUCK TIMPE
|
||||
Chief Financial Officer |
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